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| ⚫ | The '''German acupuncture trials''' ({{langx|de|GERAC-Studien<ref name=dmw1>{{cite journal |doi=10.1055/s-2005-870855 |title=Akupunktur: Was zeigen die gerac-Studien? |trans-title=Acupuncture: What of the GERAC studies? |language=de |year=2005 |last1=Wenzel |first1=K.-W |journal=Deutsche Medizinische Wochenschrift |volume=130 |issue=24 |pages=1520|pmid=15942849 }}</ref>}}) were a series of nationwide ] trials set up in 2001 and published in 2006 on behalf of several ] because of a dispute as to the usefulness of acupuncture.<ref name="spiegelacupuncture">{{cite news |first=Veronika |last=Hackenbroch |title=Die eingebildete Heilung |trans-title=The Imaginary Healing |url=http://www.spiegel.de/spiegel/print/d-32565481.html |work=] |language=de |date=2004-10-25}}</ref> They consisted of one observational study on acupuncture side effects, and four ] (RCTs) investigating acupuncture treatment for ], knee ], ] prophylaxis, and ]. The trials are considered to be one of the largest clinical studies in the field of acupuncture.<ref name="spiegelacupuncture"/> | ||
| {{medref|date=November 2013}} | |||
| {{POV|date=November 2013}} | |||
| }} | |||
| As a result of the '''GERAC''' trials, the ] ruled in April 2006 that the costs of acupuncture treatment for chronic ] and knee ] would be covered by ] in Germany,<ref name=FJC /> though no coverage was offered for headache or migraine.<ref name="Hinrichs"/> However, because of the outcome of these trials, in the case of the other conditions, ] in Germany were not convinced that acupuncture had adequate benefits over usual care or ]s.<ref name="Stuart B. Porter"/> No significant differences between acupuncture and sham acupuncture were found in any trial.<ref name=Novella>{{cite web |first=Steven |last=Novella |title=Acupuncture Doesn't Work|website=Science-Based Medicine |date=June 19, 2013 |author-link=Steven Novella|url=http://www.sciencebasedmedicine.org/acupuncture-doesnt-work/ |quote=Referencing this study: "Verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels."}}</ref> | |||
| ⚫ | ] | ||
| ⚫ | The '''German |
||
| ⚫ | According to ], the total cost of the trials amounted to 7.5 million Euros.<ref>{{cite web |title=Akupunktur |trans-title=Acupuncture |url=http://www.puls.sf.tv/Nachrichten/Archiv/2003/03/10/Gesundheitsthemen/Akupunktur |date=2003-03-10 |publisher=]}}</ref> Several years after the committee's decision to incorporate acupunctural treatment into the ] was passed into law, the number of regular users of acupuncture in the country surpassed one million.<ref name="accupuncture-rponline">{{cite news |title=Frauen häufiger mit Akupunktur behandelt |trans-title=Women treated more often with acupuncture |date=2012-08-30 |url=http://www.rp-online.de/gesundheit/medizin-und-vorsorge/frauen-haeufiger-mit-akupunktur-behandelt-1.2973239 |work=] |access-date=2013-05-23 |language=de}}</ref> | ||
| The observational study revealed ] occurring in 7.5% of all acupuncture patients. While the trial for tension-type headache had to be aborted, the other three RCTs had the same results.<ref name="GemeinsamerBundesausschuss" /> The results of the trials showed there was no difference in efficiency of real and sham acupuncture.<ref name="Howick2011">{{cite book |first=Jeremy H. |last=Howick |title=The Philosophy of Evidence-based Medicine |url=http://books.google.com/books?id=O8djbHBva5IC&pg=PA92 |year=2011 |publisher=John Wiley & Sons |isbn=9781444342666 |pages=92–4}}</ref> Subsequent assessment of the trials judged that since they did not include a well-designed placebo, they were unlikely to have emitted clinically significant findings.<ref name="Howick2011"/> | |||
| As a result of the GERAC trials, the ] ruled in April 2006 that the costs of acupunctural treatment for chronic ] and knee ] will be covered by ] in Germany.<ref name="Karin Hertzer">{{cite news |first=Karin |last=Hertzer |title=Akupunktur ist wirksam |trans_title=Acupuncture is effective |url=http://www.focus.de/gesundheit/gesundleben/alternativmedizin/chinamedizin/akupunktur/aktuelle-studie_aid_19882.html |work=] |language=de |date=2009-08-12}}</ref> | |||
| ⚫ | According to ], the total cost of the trials amounted to 7.5 million Euros.<ref>{{cite web |title=Akupunktur | |
||
| == History == | == History == | ||
| In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly |
In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly because of the lack of reliable evidence regarding its therapeutic efficacy.<ref>{{cite book |first1=Simon |last1=Singh |first2=Edzard |last2=Ernst |title=Trick Or Treatment: The Undeniable Facts about Alternative Medicine |year=2008 |publisher=W.W. Norton |location=New York |isbn=9780393066616 |pages=81–2 |edition=1st American |url=https://books.google.com/books?id=5m6CKTEr3I0C&pg=PA81}}</ref> This resulted in a heated debate, which led to Paul Rheinberger, Director of the ], saying: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."<ref>{{cite journal |last=Korzilius |first=Heike |title=Bundesausschuss: Streit um Akupunktur |journal=] |year=2000 |volume=97 |issue=30 |pages=A-2013–4 |language=de |url=http://www.aerzteblatt.de/pdf/97/30/a2013.pdf |access-date=2013-11-26}}</ref><ref>{{cite journal |doi=10.1055/s-2004-860883 |title=Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären? |year=2004 |last1=Suess |first1=Jochen |last2=Scharl |first2=Anton |journal=Die Hebamme |volume=17 |issue=4 |pages=214–7}}</ref> | ||
| In October 2000, the Federal Committee of Physicians and Health Insurers decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies.<ref name="GemeinsamerBundesausschuss" / |
In October 2000, the Federal Committee of Physicians and Health Insurers decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies.<ref name="GemeinsamerBundesausschuss" /><ref name="da1">{{cite journal |last1=Endres |first1=Heinz G. |last2=Diener |first2=Hans-Christoph |last3=Maier |first3=Christoph |last4=Böwing |first4=Gabriele |last5=Trampisch |first5=Hans-Joachim |last6=Zenz |first6=Michael |display-authors= 4 |title=Akupunktur bei chronischen Kopfschmerzen |trans-title=Acupuncture for chronic headache |journal=] |year=2007 |volume=104 |issue=3 |pages=A-114, B-105, C-101 |url=http://www.aerzteblatt.de/archiv/54176/ |language=de}}</ref> In 2001 the GERAC were set up at ]<ref name="GemeinsamerBundesausschuss" /> as a field study on behalf of six ].<ref name="spiegelacupuncture"/><ref name="da1"/> | ||
| ⚫ | == Overview and results == | ||
| Subsequently, in 2001 the GERAC were set up at ]<ref name="GemeinsamerBundesausschuss" /> as a field study on behalf of six ].<ref name="spiegelacupuncture"/><ref name="da1"/> | |||
| ⚫ | ]]] | ||
| ⚫ | == Overview == | ||
| {{Undue-section|date=November 2013}} | |||
| All RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment.<ref name="spiegelacupuncture">{{cite web|last=Veronika Hackenbroch|title=Die eingebildete Heilung|url=http://www.spiegel.de/spiegel/print/d-32565481.html|publisher='']''|language=de|date=2004-10-25|quote=Zu diesem Zweck wurden die Kranken nach dem Zufallsprinzip drei Gruppen zugeteilt: Die Schmerzpatienten der ersten Gruppe wurden nach einem chinesischen Originalverfahren gestochen, auf das sich Akupunkteure bundesweit geeinigt hatten; die Patienten der Kontrollgruppe hingegen erhielten - ohne davon zu wissen - nur die Scheinakupunktur. Eine weitere Kontrollgruppe wiederum bestand aus Patienten, die nach der schulmedizinischen Standardtherapie behandelt wurden.}}</ref> The number of patients randomized was one of the largest ever for acupuncture trials.<ref name="spiegelacupuncture"/><ref name="da1"/> | |||
| ⚫ | Beginning in 2001, the trials were carried out by ], the ], the ] and the ] for ],<ref name="GemeinsamerBundesausschuss" /><ref name="shenker">{{cite journal |last1=Pyne |first1=D. |last2=Shenker |first2=N. G. |title=Demystifying acupuncture |journal=Rheumatology |volume=47 |issue=8 |pages=1132–6 |year=2008 |pmid=18460551 |doi=10.1093/rheumatology/ken161 |doi-access=free }}</ref> ],<ref name="GemeinsamerBundesausschuss" /><ref name="Scharf et al. 2006">{{cite journal |last1=Scharf |first1=Hanns-Peter |last2=Mansmann |first2=Ulrich |last3=Streitberger |first3=Konrad |last4=Witte |first4=Steffen |last5=Krämer |first5=Jürgen |last6=Maier |first6=Christoph |last7=Trampisch |first7=Hans-Joachim |last8=Victor |first8=Norbert |title=Acupuncture and knee osteoarthritis: a three-armed randomized trial |journal=Annals of Internal Medicine |volume=145 |issue=1 |pages=12–20 |year=2006 |pmid=16818924 |doi=10.7326/0003-4819-145-1-200607040-00005 |s2cid=53090249 }}</ref> ] prophylaxis,<ref name="GemeinsamerBundesausschuss" /> and ].<ref name="GemeinsamerBundesausschuss">{{cite book |url=http://www.g-ba.de/downloads/40-268-487/2007-09-27-Abschluss-Akupunktur.pdf |title=Zusammenfassender Bericht des Unterausschusses 'Ärztliche Behandlung' des Gemeinsamen Bundesausschusses über die Bewertung gemäß §135 Abs.1 SGB V der Körperakupunktur mit Nadeln ohne elektrische Stimulation bei chronischen Kopfschmerzen, chronischen LWS-Schmerzen, chronischen Schmerzen bei Osteoarthritis |trans-title=Summary report of the subcommittee 'Medical treatment' of the Federal Joint Committee on the assessment pursuant to § 135 SGB V, Section 1 of the body acupuncture with needles without electrical stimulation for chronic headache, chronic lumbar pain, chronic pain associated with osteoarthritis |author=Gemeinsamer Bundesausschuss |date=2007-09-27 |access-date=2013-11-30 |language=de|pages=1–527}}</ref> Apart from that, an observational study on ] of acupuncture was done.<ref name="da1"/> | ||
| Only registered physicians with an additional license for acupuncture and at least two years of clinical experience in acupuncture treatment qualified as performing acupuncturists.<ref name="da1"/> In order to acquaint them with the study-specific standards of acupuncture, sham acupuncture and conventional therapy, the performing physicians received a one-day training.<ref name="da1"/> | |||
| The RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment.<ref name="spiegelacupuncture"/> The number of patients randomized was one of the largest ever for acupuncture trials.<ref name="spiegelacupuncture"/><ref name="da1"/> For each indication, around 1000 test subjects were included.<ref>{{cite journal|url=http://www.gwup.org/infos/themen-nach-gebiet/769-die-gerac-akupunkturstudien?catid=77%3Akomplementaer-und-alternativmedizin-cam |title=Die Gerac-Akupunkturstudien |author=Hessel, W. |journal=Skeptiker |issue=1 |year=2005}}</ref> The trials were conducted using sham acupuncture.<ref name=Novella/> No significant differences between acupuncture and sham acupuncture were found in any trial.<ref name=Novella/> | |||
| The acupuncture point selection was partially predetermined.<ref name="da1"/> Needles were to be manipulated until arrival of ] sensation.<ref name="da1"/> | |||
| In 2005, the '']'' (''German Medical Weekly'') published an article which criticized the trials for "not meeting scientific criteria".<ref name=dmw1/> In 2006, ], a professor of complementary medicine at the ], noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and that they " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".<ref name="Ernst-2006">{{cite journal |last1=Ernst |first1=E. |title=Acupuncture - a critical analysis |journal=Journal of Internal Medicine |volume=259 |issue=2 |pages=125–37 |year=2006 |pmid=16420542 |doi=10.1111/j.1365-2796.2005.01584.x |doi-access= }}</ref> In September 2007, ] commented on the news surrounding the study and said that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain" but that "it will be important to try to tease apart the real treatment effects from those that occur through the placebo effect".<ref name="nhsa">{{cite web|url=http://www.nhs.uk/news/2007/September/Pages/Acupuncturemaybeeffectiveforbackpain.aspx|title=Acupuncture may ease back pain|date=2007-09-26|publisher=]|access-date=January 2, 2019}}</ref> Highlighting the results of the placebo group, researchers refused to accept a ] therapy as ].<ref name="Hinrichs">{{cite book |author1=TJ Hinrichs |author2=Linda L. Barnes |page=314 |title=Chinese Medicine and Healing: An Illustrated History |edition=1 |editor1=TJ Hinrichs |editor2=Linda L. Barnes |publisher=] |year=2013 |isbn=978-0674047372}}</ref> | |||
| For sham acupuncture, needles were inserted only superficially (3 mm at most), and at bogus points; there also was no subsequent manipulation.<ref name="da1"/> Thus, only the patients (not the performing acupuncturists) could be ].<ref name="da1"/> Assessment regarding the therapy's efficacy was undertaken by blinded interviewers.<ref name="da1"/> | |||
| === Individual trials=== | |||
| ⚫ | ]]] | ||
| Beginning in 2001, the trials were carried out by the following universities: ], the ], the ] and the ]. The trials were for the following conditions: | |||
| *'''Low back pain trial''' – 1162 patients were randomized in this trial.<ref name="shenker">{{cite journal|doi=10.1093/rheumatology/ken161|title=Demystifying acupuncture|year=2008|last1=Pyne|first1=D.|last2=Shenker|first2=N. G.|journal=Rheumatology|volume=47|issue=8|pages=1132–6|pmid=18460551}}</ref> The treatment given in the standard therapy group consisted of a combination of ] and ] medication.<ref name="GemeinsamerBundesausschuss" /> | |||
| *'''Knee osteoarthritis trial''' – A total of 1039 patients were randomized in this study.<ref name="GemeinsamerBundesausschuss" /><ref name="Scharf et al. 2006">{{cite journal |doi=10.7326/0003-4819-145-1-200607040-00005 |last1=Scharf |first1=Hanns-Peter |last2=Mansmann |first2=Ulrich |last3=Streitberger |first3=Konrad |last4=Witte |first4=Steffen |last5=Krämer |first5=Jürgen |last6=Maier |first6=Christoph |last7=Trampisch |first7=Hans-Joachim |last8=Victor |first8=Norbert |displayauthors= 4 |title=Acupuncture and knee osteoarthritis: A three-armed randomized trial |journal=Annals of Internal Medicine |volume=145 |issue=1 |pages=12–20 |year=2006 |pmid=16818924}}</ref> Treatment in the standard therapy group consisted of ] or ] medication on an as-needed basis.<ref name="GemeinsamerBundesausschuss" /><ref name="Scharf et al. 2006"/> Patients in the acupuncture and sham acupuncture groups were also allowed additional medication with diclofenac (as needed), but limited to a small amount (i.e., a total of 1g between week 2 and 23).<ref name="GemeinsamerBundesausschuss" /><ref name="Scharf et al. 2006"/> Patients in all three groups could attend six physiotherapy sessions.<ref name="GemeinsamerBundesausschuss" /><ref name="Scharf et al. 2006"/> | |||
| *'''Migraine prophylaxis trial''' – In this trial, a total of 960 patients was randomized; immediately after randomization, however, 125 patients (almost all of them from the standard group) withdrew from the study.<ref name="GemeinsamerBundesausschuss" /> Primary outcome was defined as reduction in migraine days in week 21 to 25 after randomization.<ref name="GemeinsamerBundesausschuss" /> Treatment for the standard group consisted of medication according to the 2005 therapy guidelines issued by the German Neurological Association, usually comprising a ].<ref name="GemeinsamerBundesausschuss" /> | |||
| ⚫ | |||
| *'''Observational study''' – 12,617 physicians took part in the observational study, reporting on ] during or after acupuncture therapies they performed between 2001 and 2005.<ref name="da1"/> This resulted in data of roughly 2.6 million patients, out of which a random sample of 190,924 was reviewed in terms of frequency of adverse events and ]s.<ref name="da1"/> | |||
| == Domestic consequences == | == Domestic consequences == | ||
| ⚫ | As a result of the GERAC trials, in April 2006 the ], which sets ], determined that acupuncture for the treatment of low back pain and knee pain would be reimbursed by ]<ref name=FJC>{{cite web|title=Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur|url=http://www.g-ba.de/downloads/40-268-71/2006-04-18_Akupunktur-TGr.pdf|publisher=]|language=de|date=2006-04-18}}</ref> but coverage was not offered for headache or migraine.<ref name="Hinrichs"/> In July 2006, the German Health Minister ] confirmed the decision.<ref>{{cite web|title=Akupunktur wird Leistung der gesetzlichen Krankenkassen|url=http://www.bmg.bund.de/ministerium/presse/pressemitteilungen/2006-03/akupunktur-wird-leistung-der-gesetzlichen-krankenkassen.html|publisher=]|date=2006-07-03}}</ref> However, because of the outcome of these trials, in the case of the other conditions, ] in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments.<ref name="Stuart B. Porter">{{cite book |author=Stuart B. Porter |pages=408 |title=Tidy's Physiotherapy |edition=15 |editor=Stuart B. Porter |publisher=] |year=2013 |isbn=978-0702043444}}</ref> | ||
| ⚫ | |||
| ⚫ | The trials resulted in increased coverage of acupuncture in the German |
||
| === Decision of German healthcare regulators === | |||
| ⚫ | As a result of the GERAC trials, the ] |
||
| === Usage of acupuncture === | |||
| After the committee's decision to incorporate ] into the healthcare of Germany was passed into law, health insurers reported that the number of users of acupuncture in the country increased, finding favour especially among women; in 2012 there were around one million estimated users.<ref name="accupuncture-rponline"/> In 2006, German researchers published the results of one of the first, largest controlled randomized clinical trials which indicated that there was no difference between acupoints and non-acupoints.<ref name="He-2013" /> As a result of the trial's conclusions, some insurance corporations in Germany no longer reimbursed acupuncture.<ref name="He-2013" /> It also had an adverse impact on acupuncture in the international community.<ref name="He-2013">{{cite journal |pmid= 24024341 |year= 2013 |last1= He |first1= W. |last2= Tong |first2= Y. |last3= Zhao |first3= Y. |last4= Zhang |first4= L. |last5= Ben |first5= H. |last6= Qin |first6= Q. |last7= Huang |first7= F. |last8= Rong |first8= P. |displayauthors= 4 |title= Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany |volume= 33 |issue= 3 |pages= 403–7 |journal= Journal of traditional Chinese medicine}}</ref> | |||
| == International reception == | |||
| === Media === | |||
| ⚫ | ] reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment.<ref>{{cite web|last=Williams |first= Carla|title=Fake or not, acupuncture helps back pain|url= |
||
| In 2012, health insurers reported that after the committee's decision to incorporate acupuncture into the healthcare of Germany was passed into law, the number of users of acupuncture in the country had increased by about 20%, finding favour especially among women; in 2012 there were around one million estimated users.<ref name="accupuncture-rponline"/> | |||
| === Academic community === | |||
| ⚫ | == Media reception == | ||
| In September 2007, ] commented on the news surrounding the study and said that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain" but that "it will be important to try to tease apart the real treatment effects from those that occur through the placebo effect".<ref name="nhsa">{{cite web|title=Acupuncture may ease back pain|url=http://www.nhs.uk/news/2007/September/Pages/Acupuncturemaybeeffectiveforbackpain.aspx|publisher=]|date=26 September 2007|accessdate=November 2013}}</ref> {{asof|2012}} The guidance within the UK ] is that "there is little or no scientific evidence that acupuncture works for many of the conditions for which it is often used", and its use is only supported for lower back pain.<ref name=nice>{{cite web|url=http://www.nhs.uk/Conditions/Acupuncture/Pages/Introduction.aspx?url=Pages%2fWhat-is-it.aspx|title=Acupuncture|publisher=NHS Choices|date=2012-05-22|accessdate=2013-11}}</ref> | |||
| ⚫ | The trials resulted in increased coverage of acupuncture in the German media.<ref>{{cite web|title=Akupunktur bei Migräne - nicht besser als ein Placebo?|url=http://www.gwup.org/infos/nachrichten/536-akupunktur-bei-migraene-nicht-besser-als-ein-placebo|publisher=]|access-date=2013-11-26|language=de}}</ref> According to the news broadcaster ], the GERAC trials were considered to be the world's largest set of clinical studies on acupuncture.<ref>{{cite web|first=William |last=Vorsatz|title=Bestechendes Argument|url=http://www.deutschlandfunk.de/bestechendes-argument.709.de.html?dram:article_id=88197|language=de|publisher=]|date=2007-11-13}}</ref> An article in '']'' said that the results of the studies were "promising".<ref>{{cite news|title=Studie belegt: Akupunktur hilft bei chronischen Schmerzen|language=de|url=https://www.welt.de/wissenschaft/article709480/Studie-belegt-Akupunktur-hilft-bei-chronischen-Schmerzen.html|newspaper=]|date=2007-01-17}}</ref> '']'' said that the results of GERAC couldn't be brushed aside by the ].<ref name="spiegelacupuncture"/> | ||
| The trials found no significant differences between acupuncture and sham acupuncture.<ref name="Howick2011">{{cite book|author=Jeremy H. Howick|title=The Philosophy of Evidence-based Medicine|url=http://books.google.com/books?id=O8djbHBva5IC&pg=PA92|year=2011|publisher=John Wiley & Sons|isbn=9781444342666|page=92}}</ref> | |||
| ], a professor of complementary medicine at the ], noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and that they " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect".<ref>{{cite journal|doi=10.1111/j.1365-2796.2005.01584.x|title=Acupuncture - a critical analysis|year=2006|last1=Ernst|first1=E.|journal=Journal of Internal Medicine|volume=259|issue=2|pages=125–37|pmid=16420542}}</ref> | |||
| ⚫ | ] reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment.<ref>{{cite web|last=Williams |first= Carla|title=Fake or not, acupuncture helps back pain|url=https://abcnews.go.com/Health/PainManagement/story?id=3644234&page=1&singlePage=true|work=]|access-date=2013-11-25|date=2007-09-24}}</ref> Heinz Endres, one of the authors of the study, told the ] that "acupuncture has not yet been recommended as a routine therapy", but "we think this will change with our study".<ref>{{cite web|title=Acupuncture more effective than conventional treatments for back pain: Study|url=http://www.cbc.ca/news/technology/acupuncture-more-effective-than-conventional-treatments-for-back-pain-study-1.646658|publisher=]|date=2007-09-27}}</ref> The ] stated that the study "echoes the findings of two studies published last year in the '']'', which found a short course of acupuncture could benefit patients with low back pain".<ref>{{cite web|title=Needles 'are best for back pain'|url=http://news.bbc.co.uk/2/hi/7011738.stm|publisher=]|access-date=2013-11-25|date=2007-09-25}}</ref> Nigel Hawkes, health editor of '']'', wrote that the trials "suggest that both acupuncture and sham acupuncture act as powerful versions of the ]."<ref>{{cite news|first=Nigel |last=Hawkes|title=Sticking needles in a bad back 'eases pain better than drugs'|url=http://www.thetimes.co.uk/tto/health/article1962379.ece|newspaper=]|access-date=2013-11-25|date=2007-09-25}}</ref> | ||
| On June 8, 2005, the '']'' (''German Medical Weekly'') published an article which criticized the trials for "not meeting scientific criteria".<ref name=dmw1/> | |||
| == See also == | == See also == | ||
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Latest revision as of 01:24, 27 October 2024
The German acupuncture trials (German: GERAC-Studien) were a series of nationwide acupuncture trials set up in 2001 and published in 2006 on behalf of several German statutory health insurance companies because of a dispute as to the usefulness of acupuncture. They consisted of one observational study on acupuncture side effects, and four randomized controlled trials (RCTs) investigating acupuncture treatment for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. The trials are considered to be one of the largest clinical studies in the field of acupuncture.
As a result of the GERAC trials, the German Federal Joint Committee ruled in April 2006 that the costs of acupuncture treatment for chronic back pain and knee osteoarthritis would be covered by public health insurers in Germany, though no coverage was offered for headache or migraine. However, because of the outcome of these trials, in the case of the other conditions, insurance corporations in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments. No significant differences between acupuncture and sham acupuncture were found in any trial.
According to Schweizer Fernsehen, the total cost of the trials amounted to 7.5 million Euros. Several years after the committee's decision to incorporate acupunctural treatment into the healthcare of Germany was passed into law, the number of regular users of acupuncture in the country surpassed one million.
History
In the late 1990s, German healthcare regulators began to voice their doubts over the therapeutical usage of acupuncture, mostly because of the lack of reliable evidence regarding its therapeutic efficacy. This resulted in a heated debate, which led to Paul Rheinberger, Director of the Federal Committee of Physicians and Health Insurers, saying: "The higher the quality of clinical studies performed on acupuncture, the lesser the amount of evidence supporting its efficacy."
In October 2000, the Federal Committee of Physicians and Health Insurers decided that acupunctural treatment may not be reimbursed by statutory health insurance companies except within the framework of experimental field studies. In 2001 the GERAC were set up at Bochum University as a field study on behalf of six German statutory health insurance organizations.
Overview and results
Beginning in 2001, the trials were carried out by Heidelberg University, the University of Marburg, the University of Mainz and the Ruhr University Bochum for low back pain, knee osteoarthritis, migraine prophylaxis, and tension-type headache. Apart from that, an observational study on adverse events of acupuncture was done.
The RCTs were designed as three-armed trials, with the three parallel groups in each trial receiving either verum (real) acupuncture treatment, sham acupuncture treatment, or guideline-based conventional treatment. The number of patients randomized was one of the largest ever for acupuncture trials. For each indication, around 1000 test subjects were included. The trials were conducted using sham acupuncture. No significant differences between acupuncture and sham acupuncture were found in any trial.
In 2005, the Deutsche Medizinische Wochenschrift (German Medical Weekly) published an article which criticized the trials for "not meeting scientific criteria". In 2006, Edzard Ernst, a professor of complementary medicine at the University of Exeter, noted that the studies had attracted criticism for not taking into account the risk of patient de-blinding, and that they " to conclusively answer the question whether acupuncture helps patients through a specific or a nonspecific effect". In September 2007, NHS Choices commented on the news surrounding the study and said that "this trial seems to support the role of acupuncture as an effective alternative therapy for chronic lower back pain" but that "it will be important to try to tease apart the real treatment effects from those that occur through the placebo effect". Highlighting the results of the placebo group, researchers refused to accept a placebo therapy as efficient.
Domestic consequences
As a result of the GERAC trials, in April 2006 the German Federal Joint Committee, which sets health care reimbursement policy for Germany, determined that acupuncture for the treatment of low back pain and knee pain would be reimbursed by public health insurance but coverage was not offered for headache or migraine. In July 2006, the German Health Minister Ulla Schmidt confirmed the decision. However, because of the outcome of these trials, in the case of the other conditions, insurance corporations in Germany were not convinced that acupuncture had adequate benefits over usual care or sham treatments.
In 2012, health insurers reported that after the committee's decision to incorporate acupuncture into the healthcare of Germany was passed into law, the number of users of acupuncture in the country had increased by about 20%, finding favour especially among women; in 2012 there were around one million estimated users.
Media reception
The trials resulted in increased coverage of acupuncture in the German media. According to the news broadcaster Deutschlandfunk, the GERAC trials were considered to be the world's largest set of clinical studies on acupuncture. An article in Die Welt said that the results of the studies were "promising". Der Spiegel said that the results of GERAC couldn't be brushed aside by the Federal Joint Committee.
ABC News reported that the study "highlights the superiority of acupuncture", but also introduces uncertainty about the specific mechanisms of treatment. Heinz Endres, one of the authors of the study, told the Canadian Broadcasting Corporation that "acupuncture has not yet been recommended as a routine therapy", but "we think this will change with our study". The BBC stated that the study "echoes the findings of two studies published last year in the British Medical Journal, which found a short course of acupuncture could benefit patients with low back pain". Nigel Hawkes, health editor of The Times, wrote that the trials "suggest that both acupuncture and sham acupuncture act as powerful versions of the placebo effect."
See also
References
- ^ Wenzel, K.-W (2005). "Akupunktur: Was zeigen die gerac-Studien?" [Acupuncture: What of the GERAC studies?]. Deutsche Medizinische Wochenschrift (in German). 130 (24): 1520. doi:10.1055/s-2005-870855. PMID 15942849.
- ^ Hackenbroch, Veronika (2004-10-25). "Die eingebildete Heilung" [The Imaginary Healing]. Der Spiegel (in German).
- ^ "Tragende Gründe zum Beschluss des Gemeinsamen Bundesau sschusses zur Akupunktur" (PDF) (in German). Federal Joint Committee (Germany). 2006-04-18.
- ^ TJ Hinrichs; Linda L. Barnes (2013). TJ Hinrichs; Linda L. Barnes (eds.). Chinese Medicine and Healing: An Illustrated History (1 ed.). Belknap Press. p. 314. ISBN 978-0674047372.
- ^ Stuart B. Porter (2013). Stuart B. Porter (ed.). Tidy's Physiotherapy (15 ed.). Churchill Livingstone. p. 408. ISBN 978-0702043444.
- ^ Novella, Steven (June 19, 2013). "Acupuncture Doesn't Work". Science-Based Medicine.
Referencing this study: "Verum (or true) acupuncture and sham acupuncture treatments are no different in decreasing pain levels."
- "Akupunktur" [Acupuncture]. Schweizer Fernsehen. 2003-03-10.
- ^ "Frauen häufiger mit Akupunktur behandelt" [Women treated more often with acupuncture]. Rheinische Post (in German). 2012-08-30. Retrieved 2013-05-23.
- Singh, Simon; Ernst, Edzard (2008). Trick Or Treatment: The Undeniable Facts about Alternative Medicine (1st American ed.). New York: W.W. Norton. pp. 81–2. ISBN 9780393066616.
- Korzilius, Heike (2000). "Bundesausschuss: Streit um Akupunktur" (PDF). Deutsches Ärzteblatt (in German). 97 (30): A-2013–4. Retrieved 2013-11-26.
- Suess, Jochen; Scharl, Anton (2004). "Lässt sich die Wirksamkeit der Akupunktur naturwissenschaftlich erklären?". Die Hebamme. 17 (4): 214–7. doi:10.1055/s-2004-860883.
- ^ Gemeinsamer Bundesausschuss (2007-09-27). Zusammenfassender Bericht des Unterausschusses 'Ärztliche Behandlung' des Gemeinsamen Bundesausschusses über die Bewertung gemäß §135 Abs.1 SGB V der Körperakupunktur mit Nadeln ohne elektrische Stimulation bei chronischen Kopfschmerzen, chronischen LWS-Schmerzen, chronischen Schmerzen bei Osteoarthritis [Summary report of the subcommittee 'Medical treatment' of the Federal Joint Committee on the assessment pursuant to § 135 SGB V, Section 1 of the body acupuncture with needles without electrical stimulation for chronic headache, chronic lumbar pain, chronic pain associated with osteoarthritis] (PDF) (in German). pp. 1–527. Retrieved 2013-11-30.
- ^ Endres, Heinz G.; Diener, Hans-Christoph; Maier, Christoph; Böwing, Gabriele; et al. (2007). "Akupunktur bei chronischen Kopfschmerzen" [Acupuncture for chronic headache]. Deutsches Ärzteblatt (in German). 104 (3): A-114, B-105, C-101.
- Pyne, D.; Shenker, N. G. (2008). "Demystifying acupuncture". Rheumatology. 47 (8): 1132–6. doi:10.1093/rheumatology/ken161. PMID 18460551.
- Scharf, Hanns-Peter; Mansmann, Ulrich; Streitberger, Konrad; Witte, Steffen; Krämer, Jürgen; Maier, Christoph; Trampisch, Hans-Joachim; Victor, Norbert (2006). "Acupuncture and knee osteoarthritis: a three-armed randomized trial". Annals of Internal Medicine. 145 (1): 12–20. doi:10.7326/0003-4819-145-1-200607040-00005. PMID 16818924. S2CID 53090249.
- Hessel, W. (2005). "Die Gerac-Akupunkturstudien". Skeptiker (1).
- Ernst, E. (2006). "Acupuncture - a critical analysis". Journal of Internal Medicine. 259 (2): 125–37. doi:10.1111/j.1365-2796.2005.01584.x. PMID 16420542.
- "Acupuncture may ease back pain". NHS Choices. 2007-09-26. Retrieved January 2, 2019.
- "Akupunktur wird Leistung der gesetzlichen Krankenkassen". Federal Ministry of Health (Germany). 2006-07-03.
- "Akupunktur bei Migräne - nicht besser als ein Placebo?" (in German). Gesellschaft zur wissenschaftlichen Untersuchung von Parawissenschaften. Retrieved 2013-11-26.
- Vorsatz, William (2007-11-13). "Bestechendes Argument" (in German). Deutschlandfunk.
- "Studie belegt: Akupunktur hilft bei chronischen Schmerzen". Die Welt (in German). 2007-01-17.
- Williams, Carla (2007-09-24). "Fake or not, acupuncture helps back pain". ABC News. Retrieved 2013-11-25.
- "Acupuncture more effective than conventional treatments for back pain: Study". Canadian Broadcasting Corporation. 2007-09-27.
- "Needles 'are best for back pain'". BBC. 2007-09-25. Retrieved 2013-11-25.
- Hawkes, Nigel (2007-09-25). "Sticking needles in a bad back 'eases pain better than drugs'". The Times. Retrieved 2013-11-25.